TRIAL DETAIL

Phase I Vorinostat + Sorafenib in Patients With Advanced Solid Tumors

Drug:
Trial Name:
Phase I Vorinostat + Sorafenib in Patients With Advanced Solid Tumors
NCT#:
Conditions:
Solid Tumors
Status:
Unknown
Phase:
1
Start Date 03/15/2008
Age of Trial (yrs) 16.4
Treatment Phase:
Gleevec-resistant
Drug Category:
HDAC inhibitor + KIT/PDGFRA inhibitor
Strategy:
Block KIT + Unblock cell death genes + Destroy KIT
Trial Type:
GIST not specified. GIST patient enrollment unknown.
Other Protocol IDs:
07-0537
Sponsor:
Univ. of Colorado, Merck, Bayer
Patient Contact:
See site contact info below
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Official Title: A Phase I Safety and Tolerability Study of Vorinostat in Combination With Sorafenib in Patients With Advanced Solid Tumors, With Exploration of Two Tumor-Type Specific Expanded Cohorts at the Recommended Phase 2 Dose (Renal Cell Carcinoma and Non-Small Cell Lung Carcinoma)

Further study details as provided by University of Colorado at Denver and Health Sciences Center:

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: Vorinostat and sorafenib

Part A - Sorafenib bid (or qd if necessary) daily, D1-21, from cycle 1 (21 day cycle), vorinostat once daily D1-14 or D1-21 (depending on cohort).

Parts B and C - Sorafenib bid (or qd if necessary) daily, D1-21, from cycle 1 (21 day cycle), vorinostat once daily D1-14 or D1-21 (depending on cohort).

Trial Links

 

Trial Results

 
 

Drug Information

Synergistic interactions between vorinostat and sorafenib in CML cells involve Mcl-1 and p21CIP1 down-regulation (full text)
 

Trial Sites

Name
Address
City
State
Zip
Country
1665 N. Ursula St.
Aurora
CO
80045
USA